PreDiabetes Clinical Trial
Official title:
Effect of the Administration of Probiotics Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Patients With Prediabetes.
Verified date | August 2023 |
Source | University of Guadalajara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pre diabetes (PD) is a term that refers to alterations in blood glucose levels, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both, and increase in glycated hemoglobin (HbA1c), all this factors involving a higher risk to develop type 2 diabetes mellitus (T2DM). The efficacy of pharmacotherapy in the prevention of diabetes in adults with pre diabetes has been demonstrated, the first line of pharmacology treatment is metformin, on the other hand, probiotics administration has been reported to be one of the most widely used approaches to modulate the gut microbiota and subsequently prevent or delay the incidence of T2DM. Probiotics are live microorganisms which when administered in adequate amounts confer a health benefit on the host. Has been demonstrated the hypoglycemic effects of the probiotics in different clinical trials in type 2 diabetes mellitus and pre diabetes, but no yet compared with metformin, for this reason comparing it´s activity against metformin in pre diabetes would provide impact information on a new alternative treatment compared with the standard pharmacological treatment. The aim of the study is evaluate the effect of administration of probiotic versus metformin on glycemic control, insulin secretion and insulin sensitivity in patients with pre diabetes.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | December 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 31 Years to 60 Years |
Eligibility | Inclusion Criteria: - Patients both sexes - Age between 31 and 60 years - Diagnosis of prediabetes according ADA criteria (fasting blood glucose levels between 100-125 mg/dL, postprandial blood glucose levels after an oral glucose tolerance test with 75 g of oral glucose between 140-199 mg/dL and glycated hemoglobin between 5.7-6.4 %) - Body Mass Index from 25 to 34.9 kg/m2 - Stable weight at least the previous last 3 months (weight variation less than 10%) - Acceptance and signing of informed consent Exclusion Criteria: - History of kidney, liver or heart disease - Women with confirmed or suspected pregnancy - Women under lactation and/or puerperium - Physical impossibility for taking pills - Hypersensibility to ingredients of intervention - Consumption of medications or supplements with effects on glucose levels - Systolic blood pressure = 140 mmHg - Diastolic blood pressure = 90 mmHg - HbA1c =6.5% - Triglycerides = 400 mg/dL - Total cholesterol = 240 mg/dL |
Country | Name | City | State |
---|---|---|---|
Mexico | INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud | Guadalajara | Jalisco |
Lead Sponsor | Collaborator |
---|---|
University of Guadalajara |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fasting glucose levels | The fasting glucose levels will be evaluated at baseline and week 13 by enzymatic- colorimetric technique to get fasting glucose level | Baseline to week 13 (end of intervention) | |
Primary | Postpandrial glucose levels | Glucose will be evaluated at baseline and week 13 after a oral glucose tolerance test with enzymatic-colorimetric technique | Baseline to week 13 (end of intervention) | |
Primary | Glycosylated hemoglobin | Glycosylated hemoglobin will be evaluated at baseline and week 13 by high efficiency liquid chromatography. | Baseline to week 13 (end of intervention) | |
Primary | Insulin sensitivity | Insulin sensitivity will be calculated at baseline and week 13 with Matsuda index to get insuline sensitivity | Baseline to week 13 (end of intervention) | |
Primary | Total insulin secretion | Total insulin secretion will be calculated at baseline and week 13 with Insulinogenic index to get total insulin secretion | Baseline to week 13 (end of intervention) | |
Primary | First phase of insuline secretion | The first phase if insuline secretion will be calculated at baseline and week 13 with Stumvoll index to get first phase of insuline secretion | Baseline to week 13 (end of intervention) | |
Secondary | Body weight | Body weight will be measured at baseline and week 13 with a bioimpedance balance | Baseline to week 13 (end of intervention) | |
Secondary | Body mass index (BMI) | Body mass index will be calculated at baseline and week 13 with the Quetelet index formula | Baseline to week 13 (end of intervention) | |
Secondary | Waist circunference | Waist circunference will be evaluated at baseline and week 13 by World Health Organization technique | Baseline to week 13 (end of intervention) | |
Secondary | Blood pressure | Systolic blood pressure and diastolyc blood pressure will be measured at baseline and week 13 with a digital sphygmomanometer three times in each arm to get an average | Baseline to week 13 (end of intervention) | |
Secondary | Total cholesterol | Total chilesterol level will be evaluated at baseline and week 13 by enzymatic- colorimetric technique to get total cholesterol level | Baseline to week 13 (end of intervention) | |
Secondary | High density lipoprotein (c-HDL) | High density lipoprotein (c-HDL) level will be evaluated at baseline and week 13 by enzymatic- colorimetric technique to get c-HDL level | Baseline to week 13 (end of intervention) | |
Secondary | Low density lipoprotein (c-LDL) | Low density lipoprotein (c-LDL) level will be calculated at baseline and week 13 with Friedewald formula to get c-LDL level | Baseline to week 13 (end of intervention) | |
Secondary | Very low density lipoprotein (VLDL) | Very low density lipoprotein (VLDL) level will be calculated at baseline and week 13 with triglycerides concentration/5 formula to get VLDL level | Baseline to week 13 (end of intervention) | |
Secondary | Fasting blood triglycerides concentration | Fasting blood triglycerides concentration level will be evaluated at baseline and week 13 by enzymatic- colorimetric technique to get triglycerides concentration | Baseline to week 13 (end of intervention) | |
Secondary | Concentration of blood creatinine | Concentration of blood creatinine level will be evaluated at baseline and week 13 by enzymatic-colorimetric technique to get creatinine level | Baseline to week 13 (end of intervention) | |
Secondary | Concentration of blood alanine aminostranferase (ALT) | Concentration of blood alanine aminostranferase level will be evaluated at baseline and week 13 by enzymatic-colorimetric technique to get ALT level | Baseline to week 13 (end of intervention) | |
Secondary | Concentration of blood aspartate aminostranferase (AST) | Concentration of blood aspartate aminostranferase level will be evaluated at baseline and week 13 by enzymatic-colorimetric technique to get AST level | Baseline to week 13 (end of intervention) | |
Secondary | Incidence of treatment-Emergent Adverse Events | Incidence of treatment-Emergent Adverse Events of probiotics+placebo or metformin will be identified by clinical evaluation from baseline week to week 13 with continuous surveiilance | Baseline to week 13 (continuous surveiilance) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05354245 -
Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT06115265 -
Ketogenic Diet and Diabetes Demonstration Project
|
N/A | |
Completed |
NCT03188263 -
Morning Light Treatment to Improve Glucose Metabolism
|
N/A | |
Recruiting |
NCT03821961 -
18F-FDOPA PET/CT Imaging in Patients Undergoing Metabolic Surgery
|
N/A | |
Completed |
NCT04303468 -
Intervention With a GABA Supplement in Prediabetics
|
N/A | |
Recruiting |
NCT06094231 -
Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
|
N/A | |
Completed |
NCT03675360 -
Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
|
N/A | |
Completed |
NCT01910051 -
Explorative Assessment of Biomarkers in Overweight and Obese Subjects
|
||
Completed |
NCT03527368 -
The Time-Restricted Intake of Meals Study
|
N/A | |
Not yet recruiting |
NCT06453278 -
(DDS) in India: a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings
|
||
Completed |
NCT03865342 -
Prevention of Diabetes Using Mobile-enabled, Virtual Delivery of the National Diabetes Prevention Program
|
N/A | |
Suspended |
NCT03240978 -
Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese
|
N/A | |
Completed |
NCT02899390 -
Diabetes Prevention Program in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes
|
N/A | |
Recruiting |
NCT01972113 -
Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)
|
N/A | |
Completed |
NCT01436916 -
Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus
|
Phase 4 | |
Completed |
NCT01432509 -
Prospective Follow-up of a Cohort of Pre-diabetics in the North of France (DiabeNord)
|
N/A | |
Completed |
NCT00990184 -
Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)
|
Phase 3 | |
Completed |
NCT00886340 -
A Lifestyle Change Program to Prevent Type 2 Diabetes
|
Phase 2 |